This call is being recorded on Thursday, November 5, 2026. I would now like to turn the conference over to Marissa. Please go ahead.
Thank you, Marissa, and good afternoon, everyone. Thank you for joining us to review Celcuity's third quarter 2026 financial results and business update. Earlier today, Celcuity Inc. released financial results for the quarter ended September 30, 2026. The press release can be found on the investor section of Celcuity's website. Joining me on the call today are Brian Sullivan, Celcuity's Chief Executive Officer and Co-Founder, Vicky Hahne, our Chief Financial Officer, as well as Igor Gorbatchevsky, our Chief Medical Officer, and Eldon Mayer, our Chief Commercial Officer, who will both be available for questions during Q&A. Before we begin, I would like to remind listeners that our comments today include some forward-looking statements. These statements involve a number of risks and uncertainties, which are outlined in today's press release and in our reports and filings with the SEC.
Actual events or results may differ materially from those projected in the forward-looking statements. Such forward-looking statements and their implications involve known and unknown risks, uncertainties, and other factors that may cause actual results or performance to differ materially from those projected. On this call, we also refer to non-GAAP financial measures. These non-GAAP measures are used by management to make strategic decisions, forecast future results, and evaluate the company's current performance. Management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future. You can find a table reconciling the non-GAAP financial measures to GAAP measures in today's press release. With that, I would like to turn the call over to Brian Sullivan, CEO of Celcuity. Please go ahead, Brian.
Thank you, Jodi, and good afternoon, everyone. Thank you for joining our third quarter 2026 operating and financial update conference call. 2026 has been a transformative year for Celcuity as we transition to a commercial stage company. REVTORPYK is now available to U.S. physicians to prescribe for use in combination with fulvestrant, with or without palbociclib, for the treatment of HR-positive, HER2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. The unprecedented efficacy results and favorable safety profile reported from the PIK3CA wild-type cohort of the VIKTORIA-1 study provide physicians with a compelling rationale to utilize a gedatolisib regimen to address the significant unmet need for the tens of thousands of patients affected each year by advanced breast cancer.
We are pleased to report and provide our first update on the results of the foundational work our commercial and medical teams have been performing for the past two years to prepare for the commercial launch of REVTORPYK. Our launch is off to a great start, and results to date are all very encouraging. To provide insight into the effectiveness of our field team's launch activities, particularly since the drug became commercially available on September 30, we can share the following key metrics. Since REVTORPYK became commercially available on September 30, 78% of the top 36 strategic accounts have ordered REVTORPYK. These accounts treat roughly 50% of the total addressable patient population. Over 3,400 sites, many of which are affiliated with one of the top 36 strategic accounts, have directly engaged with Celcuity oncology sales specialists. These sites treat 82% of breast cancer patients.
Over 1,100 healthcare providers have attended REVTORPYK educational programs. Our market access and medical affairs teams have also been very effective. Their efforts have resulted in obtaining early and broad payer coverage and inclusion in major provider pathways so that nearly all eligible patients now have access to REVTORPYK. Within two weeks of approval, we obtained a preferred category 1 recommendation in the NCCN guidelines for the REVTORPYK triplet and doublet as a second-line treatment option for HR-positive, HER2-negative advanced breast cancer patients lacking a PIK3CA mutation. With this NCCN recommendation and the direct engagement of our team, it has had with nearly all U.S. payers over the past 18 months, 91% of U.S. commercial and Medicare lives are in healthcare plans that cover REVTORPYK.
Now, given the complexity of managing care for cancer patients, most healthcare providers adhere to treatment guidelines, most commonly referred to as treatment pathways, that provide guidance and recommendations for the physicians who work within a specific healthcare system or network. Inclusion in these pathways eliminates a critical potential barrier to physician utilization of a medicine, and this process can take, in some cases, up to 12 months. Our team, though, was able to get REVTORPYK incorporated in three of the four largest healthcare provider pathways within just 30 days of becoming commercially available. These results reflect the groundwork we have been laying for the past 24 months. During this period, we have engaged over 1,000 key opinion leaders and community breast cancer experts, key accounts, major oncology organizations, including GPOs, state societies, and special interest groups, as well as patient advocacy groups.
Our unbranded marketing campaign at pampathway.com drove awareness of the PAM pathway, with metrics that tracked well ahead of industry benchmarks. CME and third-party peer-to-peer programs and regional events have further increased levels of awareness about the importance of comprehensive PAM inhibition and the unmet need in the second-line setting. With the build-out of the commercialization infrastructure needed to support the successful launch of REVTORPYK completed, commercial launch activities for REVTORPYK commenced immediately after approval. Our 88 oncology sales specialists, who have an average of 24 years of industry experience, are calling on physicians, supporting installation of REVTORPYK order sets within the electronic health record systems of their accounts, and in-servicing infusion centers and pharmacies. Our strategic accounts, payer reimbursement, medical science liaison, and KOL-focused teams are following through on the groundwork they laid prior to REVTORPYK approval.
All of these efforts are designed to offer patients and providers with rapid access and seamless support. To enable treating physicians to obtain gedatolisib on behalf of their eligible patients after we received FDA approval and prior to commercial availability of REVTORPYK, Celcuity opened an expanded access program in mid-August. Now nearly all of the patients enrolled in this program have been transitioned to commercial product. Shipments of REVTORPYK began on September 30th at a wholesale acquisition cost of $10,000 per vial, or $30,000 per 28-day cycle of treatment. Published epidemiological data estimates there are 37,000 patients in the U.S. receiving second-line treatment for HR-positive, HER2-negative advanced breast cancer, and that based on the data from the VIKTORIA-1 trial, patients treated with the gedatolisib regimen in this setting will remain on therapy for an average of 10 treatment cycles.
Assuming net receipt of 80% of our $30,000 WAC price per cycle, we estimate the total addressable market for REVTORPYK in the second-line setting, including both PIK3CA wild-type and mutant patients, is approximately $9 billion annually. Most healthcare providers will order REVTORPYK through specialty distributors using buy-and-bill reimbursement. REVTORPYK is then drop-shipped directly to the treatment location, which is typical for infused therapies, rather than through specialty pharmacies. By selling the product through this channel, we do not obtain access to granular information such as the number of doctors prescribing or the number of patients receiving REVTORPYK. As a result, when we report sales results beginning next year, the data we will be able to provide will be limited to metrics such as gross and net sales, vials shipped, and market access-related metrics.
We expect to provide a flash report on fourth quarter sales in mid-January, and we look forward to providing further updates next year. I would like now to turn to an update on the status of our clinical development programs and recently reported data. Based on the positive data from the PIK3CA mutant cohort of the phase III VIKTORIA-1 study, we submitted a supplemental NDA to the FDA in third quarter of 2026. We expect to submit VIKTORIA-1 phase III data for both the wild-type and mutant cohorts to global regulatory authorities later this year or early next year. In October, updated results from the phase III VIKTORIA-1 study were presented in a late-breaking rapid oral presentation at ESMO.
Key results included median PFS of 21.5 months with the gedatolisib triplet and 11.5 months with the gedatolisib doublet, versus 9.1 months with alpelisib plus fulvestrant in patients who had no liver metastases. The hazard ratio for the gedatolisib triplet and doublet versus the alpelisib doublet was 0.46 and 0.71 respectively. This is a particularly important result since patients lacking liver mets represent approximately 70% of all patients treated in this setting, according to real-world analyses. Our results for patients with liver mets were also very favorable and consistent with the primary PFS analysis. For the gedatolisib triplet and doublet versus the alpelisib doublet, the hazard ratio was 0.47 and 0.38 respectively. The objective response rate for patients with evaluable disease, updated to include both confirmed and unconfirmed responders, was 59% and 43% for the gedatolisib triplet and doublet respectively, versus 33% for the alpelisib doublet.
For these patients, the median duration of response for the gedatolisib triplet and doublet was 19.4 and 27.8 months respectively, versus 7.5 months for alpelisib plus fulvestrant. The discontinuation rate for gedatolisib due to adverse events was 5% and 4% with the gedatolisib triplet and doublet respectively, compared to 19% for alpelisib plus fulvestrant. The gedatolisib treatment discontinuation rate for the mutant cohort was lower than was reported for the wild-type cohort. The higher discontinuation rate for the wild-type cohort versus the mutant cohort largely reflects the activity in one region early in the study that enrolled a significant proportion of patients in the first six months. Discontinuations fell in this region as physicians gained experience.
Since a much larger proportion of wild-type patients were enrolled during this period than mutant patients, the impact of this initial higher discontinuation rate early in the study fell disproportionately on the wild-type cohort. The mutant cohort, which enrolled more slowly initially and over a longer period of time than the wild-type cohort, we did not see disparity in discontinuation rates across regions. Thus, we believe the treatment discontinuation rate for gedatolisib reported for the mutant cohort, which was 4%-5%, best represents what we expect to see in a real-world setting. Consistent with the data from the PIK3CA wild-type cohort, the stomatitis events observed occurred primarily in the first cycle and were transient. By the second cycle of treatment, less than 3% of patients had grade 3 stomatitis, and all grade 3 events improved within one to two weeks.
Discontinuations due to stomatitis for the gedatolisib triplet and doublet were minimal, 1% and 0% respectively. Additionally, at ESMO, Dr. Sara Tolaney, Chief of the Division of Breast Oncology at the Dana-Farber Cancer Institute, presented a comparative analysis of data for the gedatolisib regimens from the PIK3CA wild-type cohort of VIKTORIA-1 and other regimens evaluated in patients with HR-positive, HER2-negative advanced breast cancer. Eight studies were included in this network meta-analysis comparing progression-free survival outcomes in randomized controlled trials of systemic treatments evaluated among patients with HR-positive, HER2-negative breast cancer who had prior CDK4/6 exposure and had PIK3CA wild-type tumors. This analysis found that the gedatolisib triplet and doublet each demonstrated statistically significant or numerically superior improvement in PFS and a progression-free survival rate at six months relative to all of the non-gedatolisib regimens evaluated.
Of note, the analysis found that patients treated with the gedatolisib triplet and doublet were two times more likely and 1.5 times more likely, respectively, at a statistically significant level, to survive without disease progression or death compared to exemestane plus abemaciclib. We expect to provide further updates to results from both the mutant and wild-type cohorts of VIKTORIA-1 at the upcoming San Antonio Breast Cancer Symposium later this year. The gedatolisib regimens have now demonstrated the potential to improve the standard of care in the second-line setting regardless of the PIK3CA status of a patient's tumor, and we believe the results from the VIKTORIA-1 study validate our pioneering approach to targeting cancers involving the PI3K/AKT/mTOR, or PAM, pathway.
Additionally, these results augur well for the phase III VIKTORIA-2 trial we have underway to advance development of gedatolisib for two different HR-positive, HER2-negative advanced breast cancer populations in the first-line setting. Results from our phase I-B clinical trial provided strong evidence that the PAM pathway is an important disease driver in treatment-naive patients with advanced breast cancer. In the early phase I study, we evaluated gedatolisib plus palbociclib and letrozole as first-line treatment in 41 patients with endocrine-sensitive, HR-positive, HER2-negative advanced breast cancer. Median PFS was 48.6 months, which compares favorably to historical data of approximately 25 months for ribociclib plus letrozole, the therapy we are using as the control in our VIKTORIA-2 trial. The objective response rate was 79% for the gedatolisib triplet, which again compares favorably to historical data of 53% for ribociclib plus letrozole.
In light of the positive results for the PIK3CA wild-type and mutant cohorts of VIKTORIA-1 and the promising preliminary data for a gedatolisib triplet as first-line treatment, we're optimistic about the results of both the first-line studies. Successful development in the first-line setting would offer the potential to advance the standard of care for the approximately 90,000 women each year who are diagnosed with late-stage HR-positive, HER2-negative advanced breast cancer in the U.S., irrespective of their endocrine sensitivity or PIK3CA status. The total addressable market for gedatolisib in the first-line setting is well over $10 billion annually. Our advancement of a subcutaneous gedatolisib formulation is ongoing, with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. Subcutaneous formulation is aimed to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years.
I'd like now to turn to our phase I-B/II clinical trial that's evaluating gedatolisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. Celcuity presented updated data from this study during a poster session at last month's ESMO Congress 2026. Key results included, median progression-free survival, or rPFS, was 15.7 months, and the six-month rPFS rate was 82.2% in patients with prior exposure to abiraterone. Median PFS was 9.1 months, and the six-month rPFS rate was 62.5% in patients with prior exposure to enzalutamide. Both sets of results compare favorably to published data for patients with either a novel hormonal therapy or docetaxel in this setting. The difference in results between patients who had prior exposure to abiraterone versus enzalutamide was expected and reflects differences in the mechanism of action of these two drugs.
For patients who had more than 50% decreases from baseline PSA, we observed them consistently across all dose levels. PSA response rates were 36%, 47%, and 67% at the 120, 180, and 240 milligram dose levels, respectively, in patients with prior exposure to either abiraterone or enzalutamide. Gedatolisib plus darolutamide demonstrated a manageable safety profile across the evaluated dose levels of 120, 180, and 240 mgs, with only one dose-limiting toxicity, which was grade 3 rash, no grade 4 or 5 treatment-related adverse events, or TRAEs, and no TRAEs leading to discontinuation of geda or death. Grade 3 TRAEs occurred in 20% of patients, with only rash and pruritus occurring in more than one patient.
A randomized phase II study to determine the recommended phase III dose level of gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer is expected to begin in the first half of 2027 after completion of the phase I-B part of this study. With programs in both breast cancer and prostate cancer reflecting the important role of the PAM pathway in these diseases, Celcuity is well-positioned to build an important pharmaceutical company over the next few years. That concludes my remarks. I would like now to hand the call over to Vicky, our CFO, to review our finances.
Thank you, Brian, and good afternoon, everyone. I will provide a brief overview of our financial results for the third quarter of 2026. Our third quarter net loss was $73.3 million, or $1.33 per share, compared to a net loss of $43.8 million, or $0.92 per share for the prior year period. Our non-GAAP adjusted net loss was $66.8 million, or $1.21 per share for the third quarter of 2026, compared to non-GAAP adjusted net loss of $37.2 million, or $0.78 per share for the prior year period. Shipments of REVTORPYK commenced on September 30, 2026. We recognize revenue when control of REVTORPYK transfers to the treatment location, which generally occurs upon delivery. Because no product was received at the treatment location until after September 30, 2026, we did not recognize any product revenue during the third quarter of 2026.
Total operating expenses were $77.3 million for the third quarter of 2026, compared to $42.8 million for the prior year period. Research and development expenses were $37.5 million for the third quarter of 2026, compared to $30.4 million for the prior year period. The $7.1 million increase was primarily due to a $5.3 million increase in employee-related and consulting expenses, and $2.1 million increase in manufacturing and other costs. These increases were partially offset by a $0.3 million decrease in clinical trial costs. Selling, general, and administrative expenses were $39.8 million for the third quarter of 2026, compared to $12.4 million for the prior year period. The $27.4 million increase was primarily due to a $14.4 million increase in employee-related expenses, primarily driven by the hiring of additional personnel within our commercial function to support the commercialization of REVTORPYK.
The remaining $13 million increase was primarily due to $11.1 million increase in cost to support the commercialization of REVTORPYK, including consulting expenses, expanding infrastructure costs, and a $1.9 million increase in other administrative expenses. In the aggregate, $25.3 million of the $27.4 million selling, general, and administrative increase related to commercial headcount additions and other activities to support the commercialization of REVTORPYK. Net cash used in operating activities for the third quarter of 2026 was $66.2 million, compared to $44.8 million for the prior year period. The additional cash used in operating activities quarter-over-quarter of $21.4 million was primarily due to non-GAAP adjusted net loss of $29.7 million, partially offset by working capital changes of $8.3 million. In addition, we made a $50 million payment to Pfizer, which was triggered by receipt of the FDA approval for REVTORPYK per our exclusive global license agreement for gedatolisib.
This payment was classified as investing activity on the condensed statement of cash flows during the third quarter of 2026. Cash, cash equivalents, and short-term investments were $642.7 million at the end of the third quarter, compared to $441.5 million as of December 31, 2025. The $201.2 million increase was primarily driven by the convertible note offering completed in June 2026. This resulted in gross proceeds of $575 million and net proceeds of $557 million. The proceeds were partially offset by $172.7 million of cash used in operating activities, the repayment of $137 million term loan, and the $50 million payment to Pfizer for the license milestone payment. Additional cash provided by investing and financing activities of $3.9 million was primarily driven by proceeds from the exercise of common stock options and employee stock purchases. We expect cash equivalents, and investments to finance our operations through 2029.
I will now hand the call back to Jodi.
Thank you, Vicky. Marissa, could you please open the call for questions?
Absolutely. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press star followed by one on your touch tone phone. You will hear a prompt that your hand has been raised. Should you wish to remove your hand from the queue, please press star followed by two. Just a moment for your first question. Your first question comes from Maury Raycroft with Jefferies. Please go ahead.
Hi. Congrats on the early progress, and thanks for taking my questions. I was going to ask, for your initial prescribers, can you say what proportion of these prescribers had prior experience with the drug through the EAP or your clinical programs, and how broad is adoption beyond those physicians?
I would say a very small percentage of the doctors prescribing were those who had participated in the VIKTORIA-1 study or who had prescribed medicine with the EAP.
Got it. Okay.
We had significant participation by those prescribers, but they did not comprise a significant proportion of the total, based on our analysis of the number of vials. We don't see specific data by doctor, so again, we can only kind of estimate what we think the impact of their involvement in the initial uptake was.
Got it. Okay. For the number of patients who enrolled in the EAP, can you say if that's a handful or a meaningful number, or are you sharing any more specifics on that?
I would say it was a handful. Again, I think as I've indicated earlier, the program became active mid-August, with the idea that it was going to become irrelevant or no longer available by the end of the third quarter, or roughly six weeks. That essentially led many physicians to indicate that the kind of work to get approval from their IRB was not going to yield their ability to enroll patients in the EAP program before our drug became commercially available. While some doctors did take advantage of it, the short timeframe when the program was believed to be relevant really disincentivized most doctors to participate in the program.
It did allow those who had either the ability because of their system's flexibility or willingness to do the work upfront to participate, and that was one of the goals, was to, for those who institutionally or personally were able to, over this short period of time, take advantage of the program, and that was a good outcome.
Got it. Okay. I'll ask one more question and then hop back in the queue. Just wondering if you can clarify if the second manufacturing site is fully operational, and is there any perspective you can share on inventory and whether there are any gating factors to maintaining a steady supply of the drug?
Yeah. I would just say that we have sufficient production to handle our planned or higher-than-planned demand from the field. We indicated that we do not expect the second site to be approved until sometime middle of 2027. That has been consistent with what we have stated previously.
Got it. Okay. Thanks for taking my questions.
You are welcome.
Your next question comes from Anupam Rama with JP Morgan. Please go ahead.
Hey, guys. Thanks so much for taking the question, and congrats on the progress here. I know in the press release you talked about 78% of your top sort of 36 priority accounts have ordered REVTORPYK. Can you give us a little bit more color on the balance of the centers and kind of what are the gating factors for them to kind of get their first order in? Thanks so much.
I would say the primary gating factor, I mean, to be frank, to put that in context, we've spoken with some people, and these accounts can be the ones that can take several months to get on. To get 78% in the first month is quite significant. But for those that didn't place an order, it was less about their lack of interest in doing so and more to do with essentially the specific organizational requirements, whether it's getting the order set fully embedded in their systems. Some of these institutions are complex organizations, or other kind of, again, more bureaucratic implementations to make the drug available. We don't anticipate that there are any true barriers other than just getting them institutionally prepared to have their doctors prescribe the medicine.
Great. Thanks so much for taking our question.
Your next question comes from Tara Bancroft with TD Cowen. Please go ahead.
Hi. Good afternoon. So obviously, your team has had a lot of touch points with the treating community. I am curious to hear from those experiences what your updated thoughts or expectations are for seeing any potential for a bolus at all, either this quarter in wild-type or in mutant patients once approval is reached there. If you are so far seeing or expecting any off-label use in the mutant segment prior to that approval, or if you think physicians will wait for the formal label. Thanks so much.
Yeah. I kind of know what you are getting at with the bolus, but again, these are sick patients, and they are not stacked up ready to go. I would say that the demand almost completely reflects patients who require a new treatment option, whether that is in the second or third line setting. We know great bulk, just based anecdotally on feedback we have received from reps and information they report back to us, that the bulk of the patients receiving the medicine are in the second line setting, which is as we would expect. But of course, there are a lot of patients in the third line setting who do not have great treatment options. Doctors are taking advantage of the availability of REVTORPYK to treat them. As far as mutant usage in patients who have PIK3CA mutations, we have certainly heard physicians have an interest.
They are very excited about the data. They would like to use it. Obviously, we are not approved to treat those patients. Our sales force does not engage in those discussions, as you would expect. To the extent that the physicians make the decision based on the data that has been reported, that they have that ability, and then they will have to work through reimbursement for the patient. But other than that, I cannot really comment on prescribing behavior with that population.
Okay, great. Yes, understood. That is very helpful. Thank you.
You are welcome.
Your next question comes from Michael Schmidt with Guggenheim. Please go ahead.
Oh, hey. Good afternoon. Thanks for taking my question. Just a few more questions, if you could share some anecdotes in terms of how you are seeing the drug use early on in terms of the types of patients that are going on to therapy relative to the VIKTORIA-1 study, and any insights on usage in either one, mutant versus wild-type patients, and perhaps split between the triplet and the doublet?
Sure. We have not really gotten much visibility on usage according to ESR1 status, to be frank. I really do not have anything to offer there. Regarding the usage of the triplet versus the doublet, that is something that our oncology sales specialists have discussed with the doctors that are looking for input and help in sorting through the data to make that decision. Again, this is anecdotal, but we see a pretty consistent pattern based on the self-reporting that we obtain from our OSSs, that the triplet is the preferred regimen by most of the doctors for most of the patients that they treat. That is consistent with the surveys we have done over the course of the past year with docs, where we present the data and ask for their decision about which therapy they would select first. Over time, we would expect that pattern to hold.
But it's early, and again, we don't get precise data, and it's primarily anecdotal, but so far, consistent with what our expectations were.
Okay, great. How should investors think about the launch trajectory, perhaps over the next 12 months, relative to some of the recent breast cancer launches? When we think about unique dynamics around J-code, for example, do you expect that to be a significant bolus for uptake next year?
Well, again, because we're an infused drug, we have to work under temporary J-code. Because we were approved after the halfway point of the year, our J-code won't become active until April 1st. We'll receive the J-code itself January 1st, but it's not active. A lot of community sites, for instance, are the ones that can be particularly affected by J-code, or leery of prescribing drugs that don't have a permanent J-code because of the reimbursement risk, in their view. But we have not found that to be a huge obstacle at this point. Certainly some. We expected that. We have reimbursement specialists in our REVTORPYK support service group that has been effective in helping community sites, for instance, navigate some of the challenges or concerns that some of these sites have about reimbursement.
We also have a program that is offering these sites extended payment terms, so that they're not at risk of essentially going upside down from a cash flow standpoint with geda, with REVTORPYK. So, while it will be an obstacle for a certain number of accounts, we bake that into the plan, but it's not an immovable object. So, we think certainly that friction will be removed when the J-code comes, but it's not an all-encompassing barrier in general.
Okay. Thank you.
Your next question comes from Gil Blum with Needham. Please go ahead.
Good afternoon, everyone, and thanks for taking our question. Really kind of on a similar topic as everyone else. Have you gotten any early feedback from your early prescribers and their experiences with the drug and how it's affected their patients? Thank you.
We have. That's actually one of the requirements that we've asked our reps to follow through on, that once they learn that a doctor or that an order has been placed to a specific site, they typically know early on, at least, it'll be easy for them to know which doctor it was. They're expected to follow up with the doctor to make sure the site is ready, has what they need, the dexamethasone mouth rinse is available at that site or that pharmacy for the patient before they come in. And then also to follow up with either the doctor or an appropriate individual at the site, the treating center, to see how the patient experienced the infusion and geda. So far, based on those types of conversations, which are happening every day across the country, the feedback has been very positive.
The patients are having a very good experience, nothing anomalous. I think our group has done a very good job of educating the relevant healthcare providers to help them understand what to expect from an adverse event standpoint, to make sure that the guidelines that we've put in place for stomatitis management have been put in place. So there've been no surprises, which is important, either for the providers or for the patients. I would say, almost universally, from the feedback we've received to date, the patient experience and the doctor's perspective on the patient's experience has been very positive.
Thank you. Very helpful.
Your next question comes from Li Watsek with Cantor. Please go ahead.
Hey, good afternoon. This is Daniel Bronder on for Li Watsek . Thank you for taking our question, and congrats on the update. We were wondering if you could comment on the potential future implications of last night's update on 340B for REVTORPYK's launch right now, but then also as you expand into the mutant population. Thank you.
Well, since our drug got approval prior to this program becoming effective, we are grandfathered in to the current discounts offered to the 340B. We do not expect this new program to affect our reimbursement rate for those hospitals. Essentially, what we've communicated to date regarding our gross-to-net estimate is consistent. We knew that that program was in place, but we were able to avoid it impacting us by getting our approval in time to get the appropriate paperwork filed, so that we would be grandfathered into the current system, or the system that preceded this one.
Thank you.
Your next question comes from Andrew Berens with Leerink Partners. Please go ahead.
Hi, guys. This is Amanda on for Andrew Berens. Maybe one quick question from us. What is the latest progress on the sub-Q formulation and how that program is going? Thank you.
Sure. It's going well. I mean, as I think discussed previously, there's a lot of different steps in this development of this new formulation. So far, we're on track to the plan that we have. We've got a number of milestones that we've identified that we need to meet in order to keep the program on track, and so far, so good. Again, it's a lot of internal work, a lot of chemistry and other formulation work, and then work to essentially isolate and quantify the general PK profile of different formulations, different approaches. There's a lot of work to do to assess stability of different formulations. So, there's a lot of variables you're optimizing, and some of them can take a meaningful period of time.
There's also significant complexity, which is the case always when you're developing a new formulation, to transfer from essentially lab scale to larger scale. All of those components of the program are factored into our timelines, and we're on track with the program overall.
Got it. Thank you.
You're welcome.
Your next question comes from Stephen Willey with Stifel. Please go ahead.
Yeah, good afternoon. Thanks for taking the questions. Maybe just to follow up on the last question. Should we expect any kind of quantitative disclosure around progress being made on the sub-Q formulation, say, over the next 12 months or so? Or will the progress updates here kind of continue to be mostly qualitative in nature?
I think for the foreseeable future, they'll be qualitative. It's a development project, and a development project is really kind of too many moving pieces to provide play-by-play, because it's hard to interpret externally. But again, we're confident about the development. We're on track with it. Some major milestones have been achieved that we expected to achieve, but it's nice to get them in the bag. So again, so far, so good.
Then maybe just, can you say if the Study 2 data updates that were presented at ESMO, were those included in the sNDA submission? I guess just any updated thoughts on how a mutant label might read with respect to either both or one of the regimens? Thanks.
We are in the middle of providing additional data to the agencies. This is part of the normal review cycle. We provided a variety of analyses, additional analysis, including some of the data that you saw in the ESMO presentation. As far as the label, again, I do not want to speculate. It is less straightforward than the wild type because the wild type had two primary endpoints with alpha assigned. The doublet was a secondary endpoint, but with no alpha assigned. That makes it less obvious, I guess, exactly how the agency will stand. Again, we have discussed that because of the nature of the expectations the agency has for powering studies to support an indication on the label. But those are the type of discussions we will be having with the agency, and we will see what we see.
Thanks for taking questions.
You are welcome.
Your next question comes from Silvan Turkcan with Citizens. Please go ahead.
Hey, good afternoon. Congrats on the quarter, and thanks for taking my question.
You are welcome.
I may be a little rusty on my CMS rules, so I just want to follow up on that change in the rule. How exactly does it work that you are grandfathered into the current discount? Do you have qualifying pass-through status, or how does that work? How much, roughly, do you expect utilization to be through the 340B hospitals? Then a second question is, how much inventory do you think sites will build in the near term, and do you have any visibility into how many weeks that could be? Thank you.
Right. Okay. We do not expect sites to really build much inventory. We drop-ship within essentially next day to the sites. It is a very quick turnaround time. There is no reason. Most sites, I think, will conclude there is no reason to build inventory. Any orders that we are getting, in our view, are linked to a particular patient and not putting drug on the shelf. As far as the 340B, again, I can say what I said before, but what I said before is what is the case. We will not be exposed to these new rules. As far as the percentage of 340B, it can vary depending on the indication. I think other companies have reported 30%-40% of business can be 340B. We are early in the process. I do not want to make a number up, but that is a useful benchmark to consider.
We have an assumption in our estimate along that range that allowed us to estimate that we think the gross to net will be 80%, 20% discount.
Great. Thank you for taking my question.
You're welcome.
Your next question comes from Oliver McCammon with LifeSci Capital. Please go ahead.
Hi. Thanks for taking my questions. I am just curious if you can remind us on the timeline to mature overall survival data from VIKTORIA-1, the process for potentially adding these data to the FDA label in the future, and then any early feedback you are hearing on how meaningful OS could be for the launch curve. Thanks again.
As far as the OS data, we have indicated previously that we expect it sometime in the first half of 2027. Again, it is event-driven, and we follow the trends. The events and OS analyses can be a little bit more unpredictable than in progression, so we have to have We are using a fairly wide time band for that estimate. As far as the label, it would only really get incorporated in the label if it is positive. Again, until we see the data, we will not know. As far as the impact it can have, I mean, certainly if it is positive, it would be impactful because, as best I know, and again, to the best of my knowledge, there has been no second-line indication showing, at least with an endocrine backbone therapy, a favorable OS advantage over the control.
Certainly, if we achieve that would be helpful, and important for the patients. I do not think there is an expectation, at least as we have discussed geda and the results with doctors, an expectation that that is required for them to make a decision on use of gedatolisib. Essentially, progression-free survival has really been the data that has been used, and then subgroup analyses to help better understand treatment effect for particularly important clinical populations. Certainly, if we were to achieve it would be a big deal. We have also indicated that because our study one, the PIK3CA wild-type cohort, allowed patients to cross over from the fulvestrant arm to the control, that creates a confounding effect.
While we showed a favorable trend, and we were encouraged by that in the interim analysis, whenever you have crossover, you just have to expect that there is going to be confounding. Again, we do not want to create any expectations of anything. We will see it when we see it. I do not think it is If the OS is not a positive result, I do not think that will have any impact on the launch.
Very helpful. Thank you.
Your next question comes from Kalpit Patel with Wolfe Research. Please go ahead.
Yeah. Hey. Good afternoon, and thanks for taking the question. A couple from us. Last time, I think, Brian, you mentioned that the NCCN guidelines could potentially include the mutant population before that approval happens. I am just curious if you have any latest thoughts on that and whether that timing could be before the year-end. Then second question, from your early experience you have so far, do you have a good sense on what is the average time from a new prescription to a patient actually starting on drug by PD, or is it too early to comment on that? Thank you.
Sure. Thanks for the questions. Regarding the NCCN guidelines for mutant patients, that is dependent on publication being available. They will only consider a publication, or rather, for an additional expansion of the recommendations based on the peer review journal article. We expect to have that available this quarter. We would then submit to the NCCN asking for a recommendation. The timing of that is difficult to project because it is somewhat dependent on their meeting schedule. Since this will not be linked to a label, it is not clear to us whether they would call an ad hoc meeting as they did for the wild-type indication. But it is not unreasonable to expect that prior to an approval decision by the FDA, that NCCN would incorporate some recommendation in their guidelines.
Okay.
Regarding the average time, we think it's quite quick. Again, this is all anecdotal. This is all self-reported from our reps. Our reps are very intimately involved, particularly in these early patients, because they've been working to essentially ride shotgun on the process with the patient. We think it's fairly quick. I mean, based on experience, when doctors identify a patient, they want to put them on therapy as soon as they can. There's not a wait-and-see approach. We're receiving demand that we think is real-time reflection of a patient requiring treatment, and the intention of giving them that treatment as soon as it's available.
Okay. If I can squeeze in a follow-up here, do you have any granularity on how many sites have actually ordered? I know you gave the number for the strategic accounts.
We'll be providing those types of updates. I appreciate the question. We'll be providing those types of updates when we provide an overview in January of the full quarter.
Okay. Thank you.
Oh, you're welcome.
Your next question comes from Silvan Turkcan with Citizens. Please go ahead.
Hey. Thanks so much for taking my follow-up. I just wanted to know if you have any takeaways from ESMO from your doctors, maybe that you engaged there with, given the presentation that you had from VIKTORIA, breaking out these different patient populations in terms of if they understand how wide you cast your net in terms of patients that you enroll versus some of these maybe mutant-selective trials that are ongoing. Did you have any feedback on-
Sure
if patients appreciated your-
No, it's sure. No, we've had conversations since we've had our approval, obviously, with a broader group of doctors. I would say there's a general understanding or recognition that we enrolled a patient population with significant disease burden that wasn't necessarily representative of the typical patient that they'll see. Really, I think the most telling statistic relates to the presence of liver mets. 70% of patients typically don't have liver mets, and liver mets are probably one of the most important factors that correlate to worse prognosis and less favorable treatment effect on an absolute basis. In our case, we had over 50% or 50% or so of patients in the mutant setting, as well as the wild type, that had liver mets. Essentially, that can act as a depressant in your absolute number.
It doesn't affect the hazard ratio, as it turns out, when you look at the subgroups, and you see the hazard ratios are comparable across subgroups depending on their tumor burden, or rather, disease burden. The data that we presented, roughly 21.5 months median PFS for the no liver mets was really important for two reasons, as I indicated in my remarks. It's essentially representative of roughly 70% of patients. That was really a fantastic result. It also highlighted and was clarifying for many docs in understanding the contribution of palbociclib, because certainly, the intent-to-treat PFS was very similar for the doublet and triplet, and so somewhat confounding. At the same time, OS trend was more favorable in the triplet than in the doublet. Again, interim analysis, so immature. People are reluctant to draw too many conclusions about that.
In this case, with the triplet versus the doublet, showed a 10-month advantage relative to the doublet, which is obviously very meaningful clinically. That really, I think, clarifies for many doctors a question they've had, "What should I start with? Should I start with the doublet or the triplet?" The feedback, I think, was fairly consistent that this really motivates them, indicates to them that it makes sense to start with the triplet. Again, that's what we're seeing in the wild-type cohort so far, anecdotally recorded. With the data at ESMO, it kind of filled in some blanks that led most of the physicians we spoke to, I think almost everyone, to prioritize use of the triplet for patients, unless there are other factors that may warrant avoidance of neutropenia, for instance.
Great. Thank you, Brian. Thanks for the details.
You're welcome.
There are no further questions at this time. I would like to turn the call back over to Brian Sullivan for closing remarks.
Thank you, everyone, for your interest in Celcuity. We look forward to reporting back in the January timeframe. Take care.
Thank you, everyone, for your participation. This concludes today's webcast and conference call. You may now disconnect.